Recruiting NCT06830850
A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-5041 Single dose of HRS-5041 orally administered.
- Who it may be relevant to
- Registry conditions: Metastatic Castration Resistant Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I, Open-label, Multi-Center, Non-Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Overview
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.
Interventions
- Drug HRS-5041 Single dose of HRS-5041 orally administered
HRS-5041 Oral dosage (Tablet) Oral dosage administration, 28 days per cycle.
Primary outcome measures
- Incidence and severity of adverse events, ECOG PS score, vital signs (pulse rate, respiratory rate, blood pressure, body temperature), ECG, clinical chemistry, hematology, urinalysis and physical examination [Time frame: Screening up to study completion, an average of 1 year.]
Secondary outcome measures (12)
- Concentration [Time frame: Screening up to study completion,an average of 1 year.]
- Cmax,ss [Time frame: From administration to C2, up to 4 months.]
- Cmin,ss [Time frame: From administration to C2, up to 4 months.]
- Objective Response Rate (ORR) [Time frame: Screening up to study completion, an average of 2 years.]
- Best of Response (DoR) [Time frame: Screening up to study completion, an average of 2 years.]
- Disease Control Rate (DCR) [Time frame: Screening up to study completion, an average of 2 years.]
- rPFS (radiographic progression-free survival [Time frame: Screening up to study completion, an average of 2 years.]
- PSA Response Rate at the end of Week 12 [Time frame: Screening up to the end of Week 12 , up to 4 months.]
- Proportion of Subjects with PSA50 (≥ 50% decline in serum PSA from baseline) [Time frame: Screening up to the end of treatment, an average of 1 year.]
- Proportion of Subjects with PSA30 (≥ 30% decline in serum PSA from baseline) [Time frame: Screening up to the end of treatment, an average of 1 year.]
- Time to PSA Progression [Time frame: From the date of first drug administration to the date of first PSA progression, an average of 1 year.]
- Overall Survival (OS) [Time frame: From the date of first drug administration to the date of death from any cause, an average of 2 year.]
Eligibility criteria
IInclusion Criteria
- Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
- Adequate bone marrow and other vital organ functions
- Adequate liver function tests
- Metastatic Castration-resistant Prostate Cancer
Exclusion criteria
- Plan to receive any other anti-tumor therapy during the study.
- Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
- Uncontrolled hypertension (systolic blood pressure \[SBP\] > 150 mmHg and/or diastolic blood pressure \[DBP\] > 100 mmHg with regular anti-hypertension therapy).
- Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.
- Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
- Active heart disease within 6 months prior to the first dosing of this study.
- Medical history of other malignant tumor within 5 years prior to dosing.
- Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 11 centers
- GenesisCare North Shore (Oncology) — Sydney
- Sydney Adventist Hospital — Sydney
- Cancer Research SA — Adelaide
- Southern Oncology Clinical Research Unit — Adelaide
- Icon Cancer Centre South Brisbane — Brisbane
- John Flynn Private Hospital — Brisbane
- Eastern Health (Box Hill Hospital) — Melbourne
- Linear Clinical Research Ltd — Perth
- … and 3 more centers
Identifiers
NCT: NCT06830850 · HRS-5041-103